EP3685805A1 - Construction acétabulaire cimentée dotée d'un manchon modulaire verrouillé - Google Patents

Construction acétabulaire cimentée dotée d'un manchon modulaire verrouillé Download PDF

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Publication number
EP3685805A1
EP3685805A1 EP20153178.7A EP20153178A EP3685805A1 EP 3685805 A1 EP3685805 A1 EP 3685805A1 EP 20153178 A EP20153178 A EP 20153178A EP 3685805 A1 EP3685805 A1 EP 3685805A1
Authority
EP
European Patent Office
Prior art keywords
liner
sleeve
acetabular
protrusions
engagement features
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP20153178.7A
Other languages
German (de)
English (en)
Other versions
EP3685805B1 (fr
Inventor
Shammodip ROY
Arlen Dale HANSSEN
Matthew P. ABDEL
Mark W. Pagnano
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Howmedica Osteonics Corp
Original Assignee
Howmedica Osteonics Corp
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Filing date
Publication date
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Publication of EP3685805A1 publication Critical patent/EP3685805A1/fr
Application granted granted Critical
Publication of EP3685805B1 publication Critical patent/EP3685805B1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A61F2002/30403—Longitudinally-oriented cooperating ribs and grooves on mating lateral surfaces of a mainly longitudinal connection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30474—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using an intermediate sleeve interposed between both prosthetic parts to be coupled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • A61F2002/30919—Sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/3401—Acetabular cups with radial apertures, e.g. radial bores for receiving fixation screws
    • A61F2002/3403—Polar aperture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/348—Additional features
    • A61F2002/3483—Additional features having a convex shape, e.g. hemispherical heads

Definitions

  • revision surgery In many instances following an initial surgery to repair a joint, a revision surgery is required, which generally involves implantation of new prostheses. Revision surgery may be required due to underlying maladies such as infection or dislocation, or simply because of the wear of the initially implanted prostheses.
  • an acetabular extraction device may be used to remove the acetabular shell, cement mantle and the inner liner.
  • the significant forces applied to the cement mantle between the acetabular elements as part of the process may still pose a high risk of damage to bone or even bone loss may occur during the extraction process. This is particularly so as the cement must be removed one small fragment at a time.
  • due to the hemispherical geometry of the cement mantle in between the acetabular shell and the inner liner it is difficult to access the cement toward the polar regions of the acetabular elements with conventional tools.
  • the present disclosure relates to an assembly with an inner hemispherical construct, also referred to as an acetabular liner, and a sleeve mechanically fixed to a surface of the inner hemispherical construct.
  • the assembly is fitted into an outer acetabular construct such as an acetabular shell in a mammalian body and secured thereto with cement.
  • the sleeve is a partial hollow hemisphere with an inner surfaces having protrusions thereon.
  • the protrusions may include two separate sets, each at a different depth of the sleeve and spaced equally from one another within one set but out of phase with each other between sets.
  • the sleeve is sized to fit over the liner in a flush manner and is further arranged to lock to the liner via the protrusions.
  • the liner includes a plurality of perimeter grooves extending circumferentially around the liner and a plurality of polar grooves extending between equatorial and polar regions of the liner. The sleeve is locked to the liner through a snap fit between each protrusion and one of the perimeter grooves.
  • the sleeve is made of a polymer while the inner hemispherical construct and the outer hemispherical construct are metallic.
  • the structure of the assembly is such that when the assembly is in place within an outer hemispherical construct, the polymer sleeve insulates cement between the metallic outer hemispherical construct and the metallic inner hemispherical construct so that the cement is only exposed to metal on one side in the equatorial region.
  • the present disclosure relates to an acetabular implant system that includes an acetabular cup, a liner and a sleeve.
  • the liner includes a convex outer surface shaped to correspond to the acetabular cup and has an equatorial region and a polar region.
  • the convex outer surface of the liner includes a plurality of liner engagement features thereon.
  • the sleeve includes an inner surface with a plurality of sleeve engagement features thereon and is sized to be flush with the convex outer surface of the liner. When the sleeve is engaged with the liner, the liner engagement features engage the sleeve engagement features.
  • the sleeve when the sleeve is engaged with the liner, the sleeve may cover a first portion of the polar region of the convex outer surface of the liner without covering a second portion of the polar region.
  • the plurality of liner engagement features may include a circumferentially extending recess parallel to a rim of the liner.
  • the plurality of sleeve engagement features may be protrusions shaped to fit within the circumferentially extending recess on the convex outer surface of the liner.
  • the plurality of liner engagement features may include a second circumferentially extending recess parallel to the rim of the liner.
  • the protrusions on the inner surface of the sleeve may include a first protrusion at a first distance from a rim of the sleeve and a second protrusion at a second distance from the rim of the sleeve.
  • the protrusions may be positioned such that the first protrusion fits within the circumferentially extending recess and the second protrusion fits within the second circumferentially extending recess.
  • the sleeve may include an outer surface with a second plurality of sleeve engagement features thereon.
  • the plurality of liner engagement features may include a plurality of recesses extending from a pole of the liner to a rim of the liner.
  • the second plurality of sleeve engagement features may include a plurality of recesses aligned with the plurality of recesses on the convex outer surface of the liner when the sleeve is engaged with the liner.
  • the plurality of liner engagement features may be one of recesses and protrusions and the plurality of sleeve engagement features may be the other of recesses and protrusions.
  • the sleeve may be a polymeric material and the liner may be a metallic material.
  • the plurality of sleeve engagement features may include a first plurality of protrusions each having a first shape and a second plurality of protrusions each having a second shape different from the first shape.
  • an acetabular implant in one embodiment, includes an acetabular cup, a liner and a sleeve.
  • the acetabular cup is adapted to seat within an acetabulum of a mammal, the liner is disposed in the acetabular cup, and the sleeve is engaged to a portion of an outer surface of the liner such that the sleeve is disposed in between the acetabular cup and the liner. With the sleeve engaged to the liner, the liner is cemented to the acetabular cup.
  • the sleeve may be a segment of a hollow sphere between two parallel planes where one of the two parallel planes bisects the hollow sphere.
  • the liner may include an equatorial region and a polar region such that the sleeve separates the liner from the acetabular cup solely in the equatorial region.
  • the cement for engagement of the liner with the sleeve is disposed between the liner and the acetabular cup over an entirety of both the equatorial region and the polar region of the liner.
  • the sleeve may include an inner surface with protrusions thereon. The protrusions may be engaged to corresponding recesses on an outer surface of the liner. In some embodiments, the recesses on the outer surface of the liner may extend circumferentially and in parallel to a rim of the liner.
  • the present disclosure relates to an acetabular implant system with a liner and a sleeve.
  • the liner includes a convex outer surface shaped to correspond to an interior of an acetabular cup and has an equatorial region and a polar region.
  • the convex outer surface of the liner includes a plurality of liner engagement features thereon.
  • the sleeve includes an inner surface with a plurality of sleeve engagement features thereon and is sized to be flush with the convex outer surface of the liner. When the sleeve is engaged with the liner, the liner engagement features engage the sleeve engagement features.
  • the sleeve when the sleeve is engaged with the liner, the sleeve may cover a first portion of the polar region of the convex outer surface of the liner without covering a second portion of the polar region.
  • the sleeve may be a segment of a hollow sphere between two parallel planes and one of the two parallel planes bisects the hollow sphere.
  • the plurality of liner engagement features may include a circumferentially extending recess parallel to a rim of the liner.
  • the plurality of sleeve engagement features may be protrusions shaped to fit within the circumferentially extending recess on the convex outer surface of the liner.
  • the plurality of liner engagement features may include a second circumferentially extending recess parallel to the rim of the liner.
  • the protrusions on the inner surface of the sleeve may include a first protrusion at a first distance from a rim of the sleeve and a second protrusion at a second distance from the rim of the sleeve. The protrusions may be positioned such that the first protrusion fits within the circumferentially extending recess and the second protrusion fits within the second circumferentially extending recess.
  • the sleeve may include an outer surface with a second plurality of sleeve engagement features thereon.
  • the plurality of liner engagement features may include a plurality of recesses extending from a location proximal to a pole of the liner to a rim of the liner.
  • the second plurality of sleeve engagement features may include a plurality of recesses aligned with the plurality of recesses on the convex outer surface of the liner when the sleeve is engaged with the liner.
  • the plurality of liner engagement features may be one of recesses and protrusions and the plurality of sleeve engagement features may be the other of recesses and protrusions.
  • the sleeve may be a polymeric material and the liner may be a metallic material.
  • the system may include the acetabular cup.
  • the liner with the sleeve engaged thereto may be cemented to the acetabular cup.
  • the cement for engagement of the liner with the acetabular cup may be disposed between the liner and the acetabular cup over an entirety of both the equatorial region and the polar region of the liner.
  • the cement for engagement of the liner with the acetabular cup may be disposed between the liner and the acetabular cup only over the polar region of the liner.
  • the present disclosure relates to a method of removal of an assembly from within an existing outer acetabular construct of a hip implant.
  • a conventional tool is used to remove the sleeve of the assembly from the inner acetabular construct of the assembly so that a void is created between the outer construct and the inner construct in the equatorial region.
  • the tool may be used to cut or chisel the sleeve and adjacent cement, and also to pull the protrusions of the sleeve from the grooves in the inner acetabular construct. Through the void created, the tool may be inserted deep toward a polar region of the inner acetabular construct to pry it out from the remaining cement engagement between the inner acetabular construct and the outer acetabular construct in the polar region.
  • the present disclosure relates to a method of removing a liner from an acetabular cup secured to an acetabulum.
  • the method of removal includes the following steps: ensuring that the acetabular cup with the liner cemented therein is accessible to an extent sufficient to remove the liner; causing a sleeve engaged to an outer surface of the liner to become disengaged from the liner; removing the sleeve such that the liner remains at least partially cemented to the acetabular cup in a polar region of the liner; and after removing the sleeve, removing the liner from the acetabular cup such that the acetabular cup remains secured to the acetabulum.
  • removing the sleeve may include removing a portion of the cement immediately in between the sleeve and the acetabular cup. In some embodiments, removing the sleeve may leave no more than 60% of an outer surface of the liner covered by cement that secures the liner to the acetabular cup. In some embodiments, causing the sleeve to become disengaged from the liner may include prying a tab on an inside surface of the sleeve from a groove on an outside surface of the liner. In some embodiments, removing the liner may involve rotating the liner relative to the acetabular cup.
  • the present disclosure relates to devices, assemblies, systems, kits and methods directed to implants used in mammalian joints, such as acetabular implants.
  • an outer acetabular construct a specific variant of which is an acetabular shell
  • an inner acetabular construct a specific variant of which is an acetabular liner.
  • Each of the outer and inner acetabular constructs are typically of a hollow hemispherical shape and are adapted for securement to each other while the outer acetabular construct is adapted for engagement to a prepared acetabular bone structure in the pelvis. This combination of outer and inner constructs is commonly used as part of a modular dual mobility acetabular implant system.
  • the present disclosure relates to a sleeve element adapted to be fixed to an inner acetabular construct, such as a liner, and how the combination of the sleeve and the inner acetabular construct improve an overall implant system when combined with an outer acetabular construct, such as an acetabular shell.
  • an outer acetabular construct such as an acetabular shell.
  • the inclusion of the sleeve locked to an outer surface of the inner acetabular construct improves the relationship between the inner and outer acetabular constructs over a life cycle of their use when compared to the relationship of the inner and outer acetabular constructs without the sleeve.
  • the present disclosure relates to an acetabular assembly that includes an inner acetabular construct, such as a liner, and a sleeve.
  • an inner acetabular construct such as a liner
  • a sleeve a sleeve
  • the inner acetabular construct is not limited to a liner and may be another similar structure.
  • FIG. 1 One embodiment of an acetabular assembly 10 with liner 30 and sleeve 60 is shown in FIG. 1 .
  • Sleeve 60 is sized and includes engagement features so that it is mechanically fixed to an outer surface of liner 30 when it is pressed thereon.
  • a combined structure of sleeve 60 and liner 30 defines assembly 10.
  • FIGs. 2B-2D Various sectional views of assembly 10 with sleeve 60 locked to liner 30 are shown in FIGs. 2B-2D , with references to a location of each sectional view identified in FIG. 2A .
  • sleeve 60 is shown in FIG. 3 .
  • the sleeve is constructed of a conventional polymeric material, though it is contemplated that the sleeve may be formed from other materials or that the material used may incorporate antibiotics.
  • Sleeve 60 is a partial hollow hemisphere without a polar region and resembles a ring.
  • An upper edge 61 of sleeve 60 also referred to as a rim, is close to a maximum circumference of the hemisphere (equivalent to an equator of a sphere), while a lower edge 62 of sleeve 60, parallel to upper edge 61, cuts the hemisphere below what would otherwise be the polar region.
  • the upper edge bisects an imaginary spherical shape based on the dimensions of the sleeve.
  • Sleeve 60 includes an outer surface 64 and an inner surface 71, which are convex and concave, respectively. It should be appreciated that although sleeve 60 is shaped to engage with a hemispherical liner or other hemispherical shaped inner acetabular construct, the concepts outlined herein may be adapted or otherwise modified for inner acetabular constructs that are not precisely hemispherical. For example, the sleeve may be shaped to engage a partial spheroid, hemispheroid, or ovoid inner acetabular construct.
  • Outer surface 64 of sleeve 60 includes a plurality of grooves thereon. It should be appreciated that in alternatives, other forms of engagement features may also be used in place of grooves. Extending around a circumference of sleeve 60 are upper perimeter groove 66 and lower perimeter groove 67. These grooves are recessed relative to outer surface 64 of sleeve. Similarly, other grooves for the sleeve and the liner described throughout the disclosure are recessed relative to respective outer surfaces of such elements. FIG. 3 illustrates that upper perimeter groove 66 is closest to an equatorial region of the sleeve shape while lower perimeter groove 67 is remote from the equatorial region relative to upper perimeter groove 66.
  • Each groove 66, 67 is defined by a rounded trough so that its side edges are at an angle relative to outer surface 64, while across the groove between the sides, the grooves are generally curved. Grooves 66, 67 are parallel to upper edge 61.
  • polar grooves 65A-65H Oriented orthogonally to perimeter grooves 66, 67 are polar grooves 65A-65H, spaced at approximately equal intervals around a perimeter of sleeve 60.
  • FIG. 3 there are eight polar grooves in total.
  • Each polar groove is of a finite length that extends between lower edge 62 and upper edge 61 at the equatorial region.
  • Polar grooves 65A-H as shown are slightly shallower within outer surface 64 than perimeter grooves 66, 67, though the relative depth between the polar grooves and the perimeter grooves may vary from that shown in FIG. 3 and may depend upon the structure of the liner or other inner structure of the construct.
  • a sectional shape of polar grooves 65A-H is a rounded trough with angled interfaces with the outer surface at each side, similar to the perimeter grooves.
  • a specific geometry of the groove shape for either the perimeter or polar grooves may also vary.
  • Each of grooves 65A-H, 66, 67 is patterned in a manner similar to the grooves on the liner, described in greater detail below.
  • the grooves are shaped and positioned so that the sleeve exhibits performance similar to the liner when in receipt of cement thereon.
  • the grooves on the sleeve enhance engagement with cement in a manner similar to that achieved with the grooves on the liner.
  • Inner surface 71 of sleeve 60 includes a plurality of sleeve engagement features in the form of protrusions thereon. Although described here in the context of protrusions, it is contemplated that other forms of engagement features may also be included on the sleeve. As shown in FIG. 3 , and also in part in FIGs. 2B-2D , inner surface 71 includes four upper protrusions 72A-D and four lower protrusions 76A-D. When the sleeve is disposed in an acetabulum, the upper protrusions are positioned laterally while the lower protrusions are positioned medially. Protrusions 72A-D, 76A-D may also be described as tabs, though it should be appreciated that the protrusions may vary from a traditional tab shape.
  • Each upper protrusion 72A-D is located at a first distance from upper edge 61 of sleeve 60.
  • upper perimeter groove 66 is located at approximately the first distance from upper edge 61. In this manner, a location relative to the upper edge is approximately the same for both upper protrusions 72A-D and upper perimeter groove 66.
  • the first distance is indicated by reference numeral 78 in FIG. 4 .
  • lower protrusions 76A-D and lower perimeter groove 67 are both located at a second distance from upper edge 61. The second distance is indicated by reference numeral 79.
  • each upper protrusion 72A-D is spaced apart at ninety degree intervals around an inner perimeter of sleeve 60, the angle measured from a center of the sleeve.
  • each lower protrusion 76A-D is also spaced apart at ninety degree intervals around the inner perimeter, although out of phase by forty five degrees relative to the upper protrusions.
  • a result of this arrangement is that a single protrusion is located at every forty five degree interval as measured from the center of the sleeve. In particular, and as shown in FIGs.
  • a sequence of the protrusions in the clockwise direction is: lower protrusion 76B, upper protrusion 72B, lower protrusion 76C, and so on.
  • the out of phase relationship between the lower protrusions and the upper protrusions is advantageous in that it is well suited for machining.
  • each upper protrusion is rectangular in shape and includes a planar elevated surface. Dimensions of the upper protrusions are approximately the same throughout their depth from the inner surface of the sleeve to the elevated surface.
  • elevated surface 73A is shown in FIG. 6 .
  • Lower protrusions 76A-D have rectangular dimensions immediately above inner surface 71, as shown in FIGs.
  • each protrusion tapers in a direction away from the inner surface to a ridge that extends over a length of the protrusion.
  • each lower protrusion has a triangular profile when viewed in a circumferential direction parallel to lower edge 62.
  • FIG. 5 illustrates lower protrusion 76A in particular, and ridge 75A that extends across its length.
  • Liner 30 is a hollow hemispherical structure as shown in FIG. 7 .
  • the liner is metallic, though it is contemplated that other materials may be used to form the liner.
  • An outer surface 34 of liner 30 extends from an equatorial edge 31 to a pole 33. Equatorial edge 31 is also referred to herein as a rim.
  • a region around pole 33 is also referred to herein as a polar region.
  • liner 30 includes a plurality of liner engagement features in the form of grooves thereon.
  • Perimeter grooves recessed in outer surface 34 extend around a perimeter of liner 30 at different distances from, and parallel to, equatorial edge 31.
  • Upper perimeter groove 36 is closest to equatorial edge 31 while lower perimeter groove 37 is further from equatorial edge 31 and closer to pole 33.
  • Eight polar grooves 35A-H are recessed in outer surface 34 and extend in a direction orthogonal to the perimeter grooves as measured at an intersection between the two. In liner 30, each polar groove is equally spaced apart around a perimeter of the outer surface.
  • Each polar groove 35AH has a length from equatorial edge 31 that extends, in a direction orthogonal to equatorial edge 31, toward a pole 33 and ends at a respective location 39A-H corresponding to a first radius centered on pole 33.
  • a polar end of each polar groove is located at a distance from pole 33 at the first radius, measured between pole 33 and any one of locations 39A-H.
  • the first radius may vary from that shown in FIG. 7 , and in this manner, the polar end of each groove may be closer or further from the pole.
  • the perimeter grooves and the polar grooves of liner 30 form rounded troughs in outer surface 34 of liner 30 such that a width of each groove between its side edges is defined by a curved surface but the side edges themselves define an angle with respect to outer surface 34.
  • the perimeter grooves are deeper than the polar grooves.
  • the grooves on liner 30, similar to the grooves on sleeve 60, are shaped and located to enhance adhesion of the liner with cement.
  • sleeve 60 includes sleeve engagement features, e.g., protrusions, for mechanical fixation of the sleeve to the liner.
  • FIGs. 2B-2D illustrate how sleeve 60 is mechanically fixed to liner 30.
  • lower protrusions 76A-D are locked, and otherwise disposed, within lower perimeter groove 37, while upper protrusions 72A-D are similarly locked within upper perimeter groove 36.
  • the inner surface of the sleeve is flush with the convex outer surface of the liner.
  • protrusions of the sleeve Disposal of the protrusions of the sleeve within grooves of the liner provides sufficient mechanical fixation to snap lock the elements to one another.
  • upper protrusions 72A-D are intended to act as snap protrusions that lock into perimeter groove 36 of the liner and resist axial forces in both directions. Since groove 36 is semi-circular in cross-section and protrusions 72A-D are rectangular in shape, press-fit contact occurs between upper protrusions 72A-D and perimeter groove 36 on at least two points of contact when the sleeve is snap fit into place on the liner.
  • each has a shape in the form of a right-angle triangle such that a base face of each lower protrusion 76A-D bottoms out on a corresponding groove face of the liner.
  • This planar contact resists axial forces that act toward the lower end of the acetabulum during cement pressurization and curing, and supplements the snap lock of upper protrusions 72A-D.
  • FIGs. 2B-2D An illustration of the engagement between the sleeve and the liner is shown in FIGs. 2B-2D , where FIG. 2B illustrates upper protrusions 72A, 72C disposed within upper perimeter groove 36 and FIG. 2D illustrates lower protrusions 76B, 76D disposed in lower perimeter groove 37.
  • FIG. 2C illustrates a section view within the forty five degrees of separation between adjacent protrusions, and accordingly no protrusions that extend inward from the sleeve are visible.
  • FIGs. 2B-2D also illustrate how grooves 65A-H, 66, 67 of sleeve 60 are generally aligned with grooves 35A-H, 36, 37, respectively, on liner 30. In this manner, when cement is used as an adhesive to secure liner 30 to an acetabular shell, the advantages of the grooves on the liner are not lost through the fixation of a sleeve to the liner, since the sleeve includes grooves on its outer surface aligned with those of the liner it covers. This is also shown in FIG. 1 .
  • the cement used for securement may be a bone cement.
  • cement is referenced throughout the disclosure as an adhesive to secure the inner and outer acetabular constructs to one another, it should be appreciated that other similar technologies may also be used as known to those of skill in the art.
  • the sleeve only covers the liner over an equatorial region of the liner.
  • One advantage of assembly 10 is that sleeve 60 is snap locked to liner 30 without any additional elements or securement materials, such as adhesives.
  • the assembly or its constituent parts including the sleeve and the inner acetabular construct may be varied in many ways.
  • the sleeve may include an inner surface with protrusions all having the same shape.
  • the protrusions may be of three or more unique shapes. A particular shape of a protrusion may vary in any way desired. For instance, where a groove on the inner acetabular construct has a unique shape, the protrusion on the sleeve may have a shape customized for fixation to such a groove.
  • the protrusions may be out of phase by 22.5 degree angles as measured from a center of the sleeve or at any other angle.
  • one set of protrusions may be out of phase from another set of protrusions by any amount desired.
  • phase separation between adjacent protrusions may vary from one pair of protrusions to the next around the perimeter of the sleeve.
  • a quantity of protrusions on the inner surface of the sleeve may be any amount deemed advantageous or practical, and may exceed the eight protrusions on the sleeve of the depicted embodiment.
  • the protrusions may be positioned at three or more separate levels on the sleeve, each level defined by a particular distance from an edge of the sleeve.
  • a shape of the protrusions in any particular level or location on the sleeve may be unique or may be part of a pattern of protrusions of that shape.
  • the perimeter and/or polar grooves on an outer surface of the sleeve may be greater or fewer in number.
  • a spacing between the grooves may be any desired amount, and may be a single spacing around the perimeter of the sleeve, or may vary from one groove to an adjacent groove.
  • the polar grooves may have an equatorial end spaced from the upper edge.
  • the polar grooves are deeper relative to the outer surface of the sleeve than the perimeter grooves.
  • any individual groove or group of grooves may have a depth different from other grooves of the sleeve.
  • an orientation of any one groove or group of grooves may be slanted so that a perimeter groove has a length at an angle relative to the upper edge of the sleeve or a polar groove is not orthogonal to the upper edge.
  • a shape of one or more grooves on the sleeve may vary in any number of ways.
  • the trough that defines each groove may be v-shaped or square shaped, for example.
  • the sleeve may have a size that corresponds to a greater or lesser portion of the outer surface of the inner acetabular construct than that of the sleeve of FIG. 1 .
  • the sleeve may have a lower edge with cut outs or a lower edge that is angled relative to the upper edge over a portion of its length.
  • the porosity of the sleeve material is sufficient to promote interdigitation with cement.
  • the liner engagement features on the inner acetabular construct may be varied in any number of ways already described for the grooves of the sleeve.
  • the inner acetabular construct may include any number of cement spacers located in any pattern or random placement.
  • the polar grooves may extend toward the pole of the inner acetabular construct in a manner such that ends of the polar grooves are immediately adjacent one another.
  • the polar grooves may vary in length relative to one another.
  • the inner acetabular construct may have one or more perimeter grooves spaced apart from one another in any amount desired.
  • the inner acetabular construct may include protrusions while the sleeve includes an inner surface with grooves or other recesses to provide a snap lock connection between the elements.
  • the engagement features on the sleeve and/or the liner such as the grooves and protrusions on the sleeve and the grooves on the liner, may be varied in any number of ways described in U.S. Pat. No. 6,758,864 and in U.S. Pat. App. Pub. No. 2015/0025647 , the disclosures of which are hereby incorporated by reference herein in their entirety.
  • a system in another aspect, includes assembly 10, an outer acetabular construct in the form of an acetabular shell, also referred to herein as an acetabular cup, and cement.
  • the acetabular shell is sized and includes features for direct engagement to a bone surface of a mammalian acetabulum.
  • the cement secures the assembly to the acetabular shell.
  • the assembly is disposed within the shell, with a gap between the outer surface of the assembly and the acetabular shell filled by the cement.
  • FIG. 11 where the acetabular shell is denoted by reference numeral 80.
  • the outer acetabular construct may be a structure other than an acetabular shell.
  • a system includes any assembly contemplated in the present disclosure secured to an outer acetabular construct with cement. It should be appreciated that a shape of the outer acetabular construct and its features may vary in accordance with the particular features of the inner acetabular construct of the assembly.
  • a kit in another aspect, includes two assemblies each with a sleeve and an inner acetabular construct, where each assembly has a unique size. In another embodiment, a kit includes two assemblies, where each assembly has a unique shape. In another embodiment, a kit includes a group of assemblies that are all the same. In yet another embodiment, a kit includes a first set of assemblies that are all the same along with a second set of assemblies different from the first set. It should be appreciated that the above embodiments are illustrative and that any combination of the above embodiments may be used to form a kit.
  • a kit includes an assembly and an outer acetabular construct, such as an acetabular shell. Any number and variety of outer acetabular constructs may be included with an assembly in a kit, and any combination of assemblies such as those described in the embodiments above may be included in a kit with one or more outer acetabular constructs. In these embodiments, a quantity of cement may also be added to the kit. In other embodiments, accessories for an acetabular implant such as implantation or removal tools, or additional components that are implanted along with the acetabular constructs may also be included.
  • kit may be varied in many ways.
  • the various combinations of elements of any contemplated kit may be included in a single package or distributed among multiple packages.
  • the kit contemplated herein may be accompanied by an instruction manual on how to perform one or more of the methods of using the contents of the kit.
  • the present disclosure relates to a method of assembling a sleeve and an inner acetabular construct to form an assembly and/or fitting the assembly into an acetabular shell.
  • sleeve 60 and liner 30 are introduced to form assembly 10. Initially, as shown in FIG. 8 , sleeve 60 is positioned over pole 33 of liner 30. Then, as shown in FIG. 9 , sleeve 60 is slid and otherwise pressed over liner 30 so that inner surface 71 of sleeve 60 becomes closer to outer surface 34 of liner 30 as the sleeve is advanced toward an equatorial region of the liner.
  • Reference numeral 102 indicates a direction of sleeve advancement.
  • sleeve 60 When lower protrusions and upper protrusions on sleeve 60 become aligned with corresponding perimeter grooves on liner 30, sleeve 60 snaps into place over liner 30 and, with sufficient mechanical fixation between the two, the sleeve becomes locked to the liner.
  • FIG. 10 illustrates the sleeve locked to the liner.
  • upper protrusions including protrusions 72A, 72C shown in FIG. 10 , are disposed within upper perimeter groove 36. Also, though not visible at the cross-section shown in FIG. 10 , the lower protrusions are disposed in lower perimeter groove 37.
  • sleeve 60 and liner 30 together define assembly 10.
  • protrusions on the sleeve are advantageous is that they provide constraint against movement and thereby lock the sleeve in place relative to the liner.
  • upper protrusions when locked into place within the upper perimeter groove of the liner, axially and rotationally constrain the sleeve relative to the liner.
  • the lower protrusions when locked into place within the lower perimeter groove of the liner, restrain movement of the sleeve relative to the liner in the axial direction. Put another way, the lower protrusions keep the sleeve from withdrawing from the liner once locked into place.
  • the axial constraint provided by the lower protrusions is sufficient so that even under pressure from cement curing between the assembly and an acetabular shell, the sleeve is restrained from slipping off the liner or otherwise becoming detached.
  • acetabular shell 80 With the sleeve and the liner locked together, assembly 10 is ready to be fit into an acetabular shell 80 positioned within an acetabulum (within surrounding bone 2) of a mammalian patient.
  • acetabular shell 80 may be newly fixed to the acetabulum as part of a new hip replacement surgery without any existing components, or it may be a preexisting acetabular shell left in place in the patient after a previously implanted inner acetabular construct and/or bearing(s) has been removed.
  • the existing construct instead of an acetabular shell, may be a cage or another outer acetabular construct. It should also be appreciated that the process of attaching an outer acetabular construct to a bone may vary as a function of the implant system utilized.
  • the shell Prior to placement of the assembly 10 into acetabular shell 80, the shell is prepared for application of cement. Then, cement 90 is applied and distributed over an inner surface 84 of shell 80. Once the application of cement 90 is deemed adequate, then assembly 10 is advanced into an opening of acetabular shell 80, as shown in FIG. 11 . A direction of the advancement is indicated by reference numeral 104. During this step, the assembly may be placed under pressure to ensure a proper fit of assembly 10 within acetabular shell 80. A fit may be considered proper when equatorial edge 31 of liner is parallel to an upper edge 81 of acetabular shell 80. When assembly 10 is properly positioned, as shown in FIG.
  • sleeve 60 is located in between outer surface 34 of liner 30 and inner surface 84 of shell 80.
  • assembly 10 is positioned and sized such that sufficient space exists between the outer surface of the sleeve and the inner surface of the acetabular shell in the equatorial region so that cement therebetween is sufficient for fixation of the respective elements. In this manner, cement is distributed within a space between the liner and the acetabular shell in at least a portion of the equatorial region and a portion of the polar region.
  • cement is disposed throughout an entirety of the space between the liner, or sleeve over it, and the acetabular shell, including an entirety of the equatorial and polar regions.
  • the sleeve may include one or more openings.
  • the liner with sleeve attached may be positioned in the acetabular shell at any stage in the preparation of an inner surface of the acetabular shell.
  • the assembly when cemented inside a metallic acetabular shell, prevents equatorial regions of the metallic liner from being directly integrated to the metallic acetabular shell by cement due to the presence of the polymeric sleeve in between. This arrangement renders it easier to remove the liner from the shell during a revision procedure.
  • a method only involves the steps of bringing together sleeve 60 and liner 30 to form assembly 10.
  • a method begins with assembly 10 already assembled. Initially, an acetabular shell is prepared through placement of cement thereon, then assembly 10 is fit into the acetabular shell in a desired manner to obtain alignment between the liner and the shell, such as is shown in FIG. 11 .
  • a method may include any number of the steps of assembling a sleeve and an inner acetabular construct and/or placing the assembly in an outer acetabular construct, and may further include steps for securement of the outer acetabular construct into an acetabulum. The steps taken to prepare the acetabulum and to secure the outer acetabular construct to the acetabulum may be those known to persons of ordinary skill in the art.
  • any embodiment or variant of the sleeve and the inner acetabular construct, including liners, contemplated by this disclosure may be used to perform a method of assembling the sleeve and inner acetabular construct to form the assembly and/or fit the assembly into an acetabular shell.
  • the liner may be used without the sleeve when implanted directly into bone, the grooves throughout the liner surface providing enhanced engagement with cement disposed in between the liner and the bone.
  • the present disclosure relates to a method of removing a liner of an acetabular implant system without removing an outer acetabular construct, such as an acetabular shell.
  • a tool 6 is brought to the surgical site and placed in between liner 30 and sleeve 60 of assembly 10.
  • Tool 6 may be any conventional tool used in revision procedures in the hip or other joints, such as an osteotome, chisel or curette.
  • sleeve 60 is removed from its locked position on the liner by pulling protrusions 72A-D, 76A-D out from within grooves 36, 37, respectively.
  • removal of the sleeve may be facilitated through cutting, deforming, chipping and/or other conventional techniques to hasten and otherwise simplify the removal of the sleeve.
  • the tool may be used to pry out the sleeve from below or from any location where grip is obtained. Because the sleeve is a polymer or other similar material, a surgeon has greater flexibility regarding techniques that may be employed to remove the sleeve from the liner.
  • the sleeve may be cut, bent or otherwise manipulated to aid in the process of removal. During this process, cement immediately in between the sleeve and the acetabular shell may be removed in part or in its entirety, as deemed necessary or otherwise advantageous under the circumstances.
  • a sleeve is removed from the liner, no more than 60% of an outer surface area of the liner is covered by cement that remains engaged the acetabular shell after removal. In other examples, 35% to 45% of the outer surface area of the liner remains engaged to the acetabular shell by cement after removal.
  • less than 40% of the polar grooves and none of the perimeter grooves are covered by cement that engages the liner to the acetabular shell after removal of the sleeve.
  • FIG. 13 illustrates the liner and the acetabular shell within the body once the sleeve is removed, as indicated by reference numeral 114.
  • a void 98 is left between liner 30 and shell 80 in the equatorial region where the sleeve was previously disposed.
  • cement 90 which only binds liner 30 with acetabular shell 80 in a polar region, located approximately over a portion of liner 30 bound to shell 80 by cement 90 as shown in FIG. 13 . Because of this void 98, access to deeper regions of the liner is made possible.
  • Tool 6 or another tool is used at this juncture to move, rock and/or rotate liner 30 relative to acetabular shell 80 to weaken the cement based securement of the liner to the shell.
  • an osteotome may be used to lever out the liner. Because only a small portion of the shell and the liner are engaged by cement, the cement interface between the two is weakened significantly compared to a cement interface spanning an entire hemisphere of the respective acetabular constructs, thereby lessening the force required to remove the liner from the shell to a significant degree. Also, because of the significant depth accessible between the liner and the shell within void 98, the tool may be used with increased leverage to lever out the liner when compared to a fully cemented pair of acetabular constructs.
  • this method also significantly reduces the risk of removing or damaging bone structures in and around the acetabulum.
  • the liner may be removed predictably in a relatively short period of time. Once the liner removal process is complete, a new liner may be implanted and locked while leaving an existing acetabular shell in place.
  • the devices and methods of the disclosure are particularly well adapted for acetabular constructs that form a modular dual mobility system, but may also be employed in other circumstances where two metal constructs are intended to be cemented to one another.
  • the assembly can be used with dual mobility bearings placed inside of the inner construct and an outer surface of the inner construct cemented to the outer construct with cement spacers placed at predetermined, spaced locations on the outer surface of the inner construct.
  • the assembly is advantageous for use in methods of securing an inner construct, e.g., acetabular liner, to an outer construct, e.g., acetabular shell, where both the inner and outer constructs are metallic. It is advantageous in that it is easily revisable, modular and may be employed in dual mobility hip implant systems, either as a new implant or as a replacement. Another advantage of the assembly is that grooves on outer surfaces of the sleeve and the liner are exposed for receipt of cement to engage the assembly to the outer construct.
  • the inner construct may be cemented to the outer construct or to a bone without the sleeve. The inner construct may be provided without the sleeve, or the sleeve may be unlocked from the inner construct to prepare for such use. This configuration may be desirable when the inner construct is intended for cementing directly onto a bone surface.
  • Yet another advantage is the matching geometry of the grooves on the sleeve and the inner construct.
  • the grooves of the sleeve are aligned with the grooves on the inner construct that are covered by the sleeve.
  • those portions exist on the sleeve at approximately the same radial location as extant on the liner.
  • the assembly when cemented to an outer acetabular construct, produces similar cement coverage and cement fixation as that obtainable when the inner construct is cemented by itself directly to an outer construct or to bone.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
EP20153178.7A 2019-01-25 2020-01-22 Construction acétabulaire cimentée dotée d'un manchon modulaire verrouillé Active EP3685805B1 (fr)

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WO2019171138A1 (fr) * 2018-03-07 2019-09-12 Cossington Limited Dispositif écarteur cotyloïdien comprenant une substance pharmaceutique
WO2024194376A1 (fr) * 2023-03-22 2024-09-26 Depuy Ireland Unlimited Company Insert pour régler l'épaisseur du manteau de ciment

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